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K Number
K211390
Device Name
Nitrile Blue Powder-free Examination Glove
Manufacturer
Cardinal Health 200, LLC
Date Cleared
2021-08-28

(115 days)

Product Code
LZALZC
Regulation Number
880.6250
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves have been tested for resistance to permeation of various chemotherapy drugs per ASTM D6978, "Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs."
Device Description
Nitrile Blue Powder-Free Examination Gloves
More Information

Not Found

Not Found

No
The device is a disposable examination glove, and the description focuses on its material and resistance to chemotherapy drugs. There is no mention of AI or ML capabilities.

No
The device, examination gloves, is intended to prevent contamination and resist chemotherapy drugs, not to treat a disease or condition.

No
The device is a patient examination glove used to prevent contamination, not to diagnose a medical condition.

No

The device description clearly identifies the device as "Nitrile Blue Powder-Free Examination Gloves," which are physical hardware. The summary focuses on the physical properties and testing of these gloves, not software functionality.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
  • Device Function: The description clearly states the device is a "patient examination glove" intended to be worn on the hand or finger to prevent contamination. Its primary function is a physical barrier.
  • Lack of Specimen Analysis: The device does not interact with or analyze any specimens taken from the patient's body.
  • Testing for Permeation: While the gloves are tested for resistance to chemotherapy drugs, this testing is about the integrity and barrier properties of the glove itself, not about diagnosing or analyzing a patient's condition based on a specimen.

Therefore, based on the provided information, the device is a medical device, but it falls under a different category than In Vitro Diagnostics.

N/A

Intended Use / Indications for Use

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves have been tested for resistance to permeation of various chemotherapy drugs per ASTM D6978, "Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs."
Chemotherapy Drug Permeation Resistance (minimum breakthrough detection time in minutes, 0.01 µg/cm2/min):

  1. Azacitidine (Vidaza) (25 mg/ml) >= 240
  2. Bendamustine (5 mg/ml) >= 240
  3. Bleomycin (15 mg/ml) >= 240
  4. Bortezomib (Velcade) (1 mg/ml) >= 240
  5. Busulfan (6 mg/ml) >= 240
  6. Carboplatin (10 mg/ml) >= 240
  7. Carfilzomib (2 mg/ml) >= 240
  8. Carmustine BCNU (3.3 mg/ml) 14.7 (Do not use)
  9. Cetuximab (Erbitux) (2 mg/ml) >= 240
  10. Cisplatin (1.0 mg/ml) >= 240
  11. Cyclophosphamide (Cytoxan) (20 mg/ml) >= 240
  12. Cytarabine HCl (Cytosine) (100 mg/ml) >= 240
  13. Cytovene (10 mg/ml) >= 240
  14. Dacarbazine DTIC (10 mg/ml) >= 240
  15. Daunorubicin (5.0 mg/ml) >= 240
  16. Decitabine (5 mg/ml) >= 240
  17. Docetaxel (10.0 mg/ml) >= 240
  18. Doxorubicin Hydrochloride (2.0 mg/ml) >= 240
  19. Ellence (Epirubicin) (2 mg/ml) >= 240
  20. Eribulin Mesylate (0.5 mg/ml) >= 240
  21. Etopside Toposar (20 mg/ml) >= 240
  22. Fludarabine (25 mg/ml) >= 240
  23. Fluorouracil (5-Fluorouracil / Adrucil) (50mg/ml) >= 240
  24. Fulvestrant (50 mg/ml) >= 240
  25. Gemcitabine (38.0 mg/ml) >= 240
  26. Idarubicin (1.0 mg/ml) >= 240
  27. Ifosfamide (50.0 mg/ml) >= 240
  28. Irinotecan HCl (20.0 mg/ml) >= 240
  29. Mechlorethamine HCl (1.0 mg/ml) >= 240
  30. Melphalan (5 mg/ml) >= 240
  31. Methotrexate (25 mg/ml) >= 240
  32. Mitomycin-C (0.5 mg/ml) >= 240
  33. Mitoxantrone (2.0 mg/ml) >= 240
  34. Oxaliplatin (5 mg/ml) >= 240
  35. Paclitaxel (Taxol) (6 mg/ml) >= 240
  36. Pemetrexed (25 mg/ml) >= 240
  37. Pertuzumab (30 mg/ml) >= 240
  38. Raltitrexed (0.5 mg/ml) >= 240
  39. Retrovir (10 mg/ml) >= 240
  40. Rituximab (10 mg/ml) >= 240
  41. Temsirolimus (25 mg/ml) >= 240
  42. Thiotepa (10 mg/ml) 39.4 (Do not use)
  43. Topotecan HCL (1 mg/ml) >= 240
  44. Trastuzumab (21 mg/ml) >= 240
  45. Triclosan (1 mg/ml) >= 240
  46. Trisenox (Arsenic Trioxide) (1 mg/ml) >= 240
  47. Vinblastine (1 mg/ml) >= 240
  48. Vincristine Sulfate (1.0 mg/ml) >= 240
  49. Vinorelbine (10 mg/ml) >= 240
  50. Zoledronic Acid (0.8 mg/ml) >= 240
    The maximum testing time is 240 minutes. Please note that Carmustine (BCNU) (3.3 mg/ml) and Thiotepa (10 mg/ml) have extremely low permeation times and should not be used with this glove.

Product codes

LZA, LZC

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Not Found

Reference Device(s)

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Predetermined Change Control Plan (PCCP) - All Relevant Information

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§ 880.6250 Non-powdered patient examination glove.

(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 28, 2021

Cardinal Health 200, LLC William Cisneros Sr. Regulatory Affairs Specialist 3651 Birchwood Drive Waukegan, Illinois 60085

Re: K211390

Trade/Device Name: Nitrile Blue Powder-free Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: July 30, 2021 Received: August 3, 2021

Dear William Cisneros:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

1

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Clarence W. Murray III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K211390

Device Name

Nitrile Blue Powder-Free Examination Gloves

Indications for Use (Describe)

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves have been tested for resistance to permeation of various chemotherapy drugs per ASTM D6978, "Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs."

Chemotherapy Drug Permeation Resistance (minimum breakthrough detection time in minutes, 0.01 µg/cm2/min):

1. Azacitidine (Vidaza)(25 mg/ml) ≥ 240
2. Bendamustine(5 mg/ml) ≥ 240
3. Bleomycin(15 mg/ml) ≥ 240
4. Bortezomib (Velcade)(1 mg/ml) ≥ 240
5. Busulfan(6 mg/ml) ≥ 240
6. Carboplatin(10 mg/ml) ≥ 240
7. Carfilzomib(2 mg/ml) ≥ 240
8. Carmustine BCNU(3.3 mg/ml) 14.7 (Do not use)
9. Cetuximab (Erbitux)(2 mg/ml) ≥ 240
10. Cisplatin(1.0 mg/ml) ≥ 240
11. Cyclophosphamide (Cytoxan)(20 mg/ml) ≥ 240
12. Cytarabine HCl (Cytosine)(100 mg/ml) ≥ 240
13. Cytovene(10 mg/ml) ≥ 240
14. Dacarbazine DTIC(10 mg/ml) ≥ 240
15. Daunorubicin(5.0 mg/ml) ≥ 240
16. Decitabine(5 mg/ml) ≥ 240
17. Docetaxel(10.0 mg/ml) ≥ 240
18. Doxorubicin Hydrochloride(2.0 mg/ml) ≥ 240
19. Ellence (Epirubicin)(2 mg/ml) ≥ 240
20. Eribulin Mesylate(0.5 mg/ml) ≥ 240
21. Etopside Toposar(20 mg/ml) ≥ 240
22. Fludarabine(25 mg/ml) ≥ 240
23. Fluorouracil (5-Fluorouracil / Adrucil)(50mg/ml) ≥ 240
24. Fulvestrant(50 mg/ml) ≥ 240
25. Gemcitabine(38.0 mg/ml) ≥ 240
26. Idarubicin(1.0 mg/ml) ≥ 240
27. Ifosfamide(50.0 mg/ml) ≥ 240
28. Irinotecan HCl(20.0 mg/ml) ≥ 240
29. Mechlorethamine HCl(1.0 mg/ml) ≥ 240
30. Melphalan(5 mg/ml) ≥ 240
31. Methotrexate(25 mg/ml) ≥ 240
32. Mitomycin-C(0.5 mg/ml) ≥ 240
33. Mitoxantrone(2.0 mg/ml) ≥ 240
34. Oxaliplatin(5 mg/ml) ≥ 240
35. Paclitaxel (Taxol)(6 mg/ml) ≥ 240
36. Pemetrexed(25 mg/ml) ≥ 240
37. Pertuzumab(30 mg/ml) ≥ 240
38. Raltitrexed(0.5 mg/ml) ≥ 240
39. Retrovir(10 mg/ml) ≥ 240
40. Rituximab(10 mg/ml) ≥ 240
41. Temsirolimus(25 mg/ml) ≥ 240
42. Thiotepa(10 mg/ml) 39.4 (Do not use)
43. Topotecan HCL(1 mg/ml) ≥ 240
44. Trastuzumab(21 mg/ml) ≥ 240
45. Triclosan(1 mg/ml) ≥ 240
46. Trisenox (Arsenic Trioxide)(1 mg/ml) ≥ 240
47. Vinblastine(1 mg/ml) ≥ 240
48. Vincristine Sulfate(1.0 mg/ml) ≥ 240
49. Vinorelbine(10 mg/ml) ≥ 240
50. Zoledronic Acid(0.8 mg/ml) ≥ 240

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The maximum testing time is 240 minutes. Please note that Carmustine (BCNU) (3.3 mg/ml) and Thiotepa (10 mg/ml) have extremely low permeation times and should not be used with this glove.

Type of Use (Select one or both, as applicable)

_ | Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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